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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
24 mg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
2.5
Dose descriptor starting point:
NOAEC
Value:
34 mg/m³
Modified dose descriptor starting point:
NOAEC
Value:
60 mg/m³
Explanation for the modification of the dose descriptor starting point:

A corrected inhalatory NOAEC rat was calculated on the basis of the oral NOAEL rat (34 mg/kg bw/day) by using a default respiratory volume for the rat corresponding to the daily duration of human exposure (sRVrat; see ECHA Guidance R.8. 2012).

The NOAEL for HEDP-xK (41 mg/kg bw/day) is equivalent to 34 mg active acid/kg bw/day.

The following correction was made to the NOAEL (oral): Correction respiratory volume rat (8 hour) 1/0.38 m³/kg bw/day, Correction for respiratory volume (worker): 6.7 m³/10 m³. Correction for oral to inhaled 1/2. Therefore the corrected NOAEC for repeated-dose systemic effects via the inhalation route is: 34*(1/0.38) *(6.7 m³/10 m³)*(1/2) = 30.0 mg/m³.

For both oral and inhalation exposure, an absorption of 5% was assumed. Therefore, the corrected NOAEC is 60.0 mg/m³.

AF for dose response relationship:
1
AF for differences in duration of exposure:
1
Justification:
Default value for chronic study
AF for interspecies differences (allometric scaling):
1
Justification:
Default for inhalation exposure
AF for other interspecies differences:
2.5
Justification:
Default for interspecies differences
AF for intraspecies differences:
1
Justification:
Effect is based on physical properties of the registered substance (ability to bind metal ions) and the lower NOAEL for juvenile animals is used rather than the NOAEL based on findings for the completed chronic study. Therefore, the NOAEL is precautionary and already accounts for intraspecies differences.
AF for the quality of the whole database:
1
AF for remaining uncertainties:
1
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
34 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
10
Modified dose descriptor starting point:
NOAEL
Value:
340 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

The oral NOAEL for HEDP-xK (41 mg/kg bw/day) is equivalent to 34 mg active acid/kg bw/day.

For oral exposure, an absorption of 5% was assumed (see chapter toxicokinetics). For dermal exposure, an absorption of 0.5% was assumed (see chapter toxicokinetics). Therefore, the NOAEL can be corrected by a factor of 10.

AF for dose response relationship:
1
AF for differences in duration of exposure:
1
Justification:
Chronic oral study
AF for interspecies differences (allometric scaling):
4
Justification:
Default value
AF for other interspecies differences:
2.5
Justification:
Default value
AF for intraspecies differences:
1
Justification:
Effect is based on physical properties of the registered substance (ability to bind metal ions) and the lower NOAEL for juvenile animals is used rather than the NOAEL based on findings for the completed chronic study. Therefore, the NOAEL is precautionary and already accounts for intraspecies differences.
AF for the quality of the whole database:
1
AF for remaining uncertainties:
1
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - workers

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
12 mg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
2.5
Modified dose descriptor starting point:
NOAEC
Value:
30 mg/m³
Explanation for the modification of the dose descriptor starting point:

A corrected inhalatory NOAEC rat was calculated on the basis of the oral NOAEL rat (34 mg/kg bw/day) by using a default respiratory volume for the rat corresponding to the daily duration of human exposure (sRVrat; see ECHA Guidance R.8. 2012).

The NOAEL for HEDP-xK (41 mg/kg bw/d) is equivalent to 34 mg active acid/kg bw/day.

The following correction was made to the NOAEL (oral): Correction respiratory volume rat (24 hour) 1/1.15 m³/kg bw. Correction for oral to inhaled 1/2. Therefore the corrected NOAEC for repeated-dose systemic effects via the inhalation route is: 34*(1/1.15)*(1/2) = 15.0 mg/m³.

For both oral and inhalation exposure, an absorption of 5% was assumed, therefore the modified dose description starting point is 30.0 mg/m³.

AF for dose response relationship:
1
AF for differences in duration of exposure:
1
Justification:
Default value for chronic oral study
AF for interspecies differences (allometric scaling):
1
Justification:
Default value for inhalation
AF for other interspecies differences:
2.5
Justification:
Default
AF for intraspecies differences:
1
Justification:
Effect is based on physical properties of the registered substance (ability to bind metal ions) and the lower NOAEL for juvenile animals is used rather than the NOAEL based on findings for the completed chronic study. Therefore, the NOAEL is precautionary and already accounts for intraspecies differences.
AF for the quality of the whole database:
1
AF for remaining uncertainties:
1
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
34 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
10
Modified dose descriptor starting point:
NOAEL
Value:
340 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

The NOAEL for HEDP-xK (41 mg/kg bw/d) is equivalent to 34 mg active acid/kg bw/day.

For oral exposure, an absorption of 5% was assumed (see chapter toxicokinetics). For dermal exposure, an absorption of 0.5% was assumed (see chapter toxicokinetics). Therefore, the NOAEL can be corrected by a factor of 10.

AF for dose response relationship:
1
AF for differences in duration of exposure:
1
Justification:
Default value for a chronic oral study
AF for interspecies differences (allometric scaling):
4
Justification:
Default value
AF for other interspecies differences:
2.5
Justification:
Default value
AF for intraspecies differences:
1
Justification:
Effect is based on physical properties of the registered substance (ability to bind metal ions) and the lower NOAEL for juvenile animals is used rather than the NOAEL based on findings for the completed chronic study. Therefore, the NOAEL is precautionary and already accounts for intraspecies differences.
AF for the quality of the whole database:
1
AF for remaining uncertainties:
1
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
3.4 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
10
Modified dose descriptor starting point:
NOAEL
Value:
34 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

The NOAEL for HEDP-xK (41 mg/kg bw/d) is equivalent to 34 mg active acid/kg bw/day from an oral repeated dose toxicity study. Therefore, no corrections are applied to the NOAEL.

AF for dose response relationship:
1
AF for differences in duration of exposure:
1
Justification:
Chronic oral study
AF for interspecies differences (allometric scaling):
4
Justification:
Default value
AF for other interspecies differences:
2.5
Justification:
Default value
AF for intraspecies differences:
1
Justification:
Effect is based on physical properties of the registered substance (ability to bind metal ions) and the lower NOAEL for juvenile animals is used rather than the NOAEL based on findings for the completed chronic study. Therefore, the NOAEL is precautionary and already accounts for intraspecies differences.
AF for the quality of the whole database:
1
AF for remaining uncertainties:
1
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
3.4 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
10
DNEL extrapolated from long term DNEL

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - General Population